"Do you have all important environmental conditions in view at all times?"

Testo Pharma Solutions 

If pharmaceuticals are produced and stored under the wrong climatic conditions, the stability and therefore the efficacy of the drugs can suffer as a result.

Testo can support you in a GMP-regulated environment with: 

  • Best-in-class data monitoring system
  • All-in-one solution
  • 100% audit-safe



"We guarantee a 100% audit approved data monitoring system!"




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Everything in view at all times:
Environmental monitoring with testo Saveris 1

Continuous monitoring and documentation of environmental parameters such as temperature, humidity or differential pressure can quickly become a challenge.

The industry-leading monitoring solution testo Saveris 1 provides automated and efficient support in complying with your regulatory requirements.

Best in class software

The testo Saveris software enables comprehensive analysis and evaluation of all recorded measurement parameters - with access from anywhere:

  • Detailed logging functions and secure archiving of measurement data
  • Audit-proof central data management platform 
  • Meets requirements of the FDA regarding 21 CFR Part 11 and Annex 11 of the EU GMP Directive.

Broad portfolio of hardware

Our precise and reliable sensor technology forms the basis of our measurement solutions. We rely on state-of-the-art technologies and strict quality controls to ensure that our sensors deliver accurate measurement results:

  • Digital probes
  • Different communication technologies ( wifi - ethernet - ultrarange)
  • Triple storage of data

Our extensive offering of services

Our specially GxP-trained service team accompanies you through all process steps in a customer-oriented and systematic way:

  • Temperature mappings
  • System qualification 
  • Software validation 
  • Maintenance
  • Calibration (ISO17025 & ISO9001)

Our applications

Through our collaboration with pharmaceutical companies, we've had the privilege of contributing to projects in these fields:

  • Hospitals
  • Pharma logistics
  • R&D
  • Laboratories
  • Cleanrooms
  • Blood banks
  • Biotech

References

SETUP, FUNCTION AND TARGETED ALARMING FOR MAXIMUM QUALITY ASSURANCE


 Find out how the testo Saveris 1 environmental monitoring system ensures continuous monitoring and seamless control of your critical parameters. Discover how targeted alarms prevent material damage and ensure the quality of your products and processes. From real-time alerting to integration into other systems – we explain how our system triggers alarms and thus supports compliance and process safety. 

"Are You in Compliance with the Upcoming PIC/S Standards?" 


Starting from January 1, 2026, the new PIC/S standard will come into effect for hospital pharmacists in Belgium. This standard imposes strict requirements on quality management and the production of medicines in hospital pharmacies, with a focus on compliance with Good Manufacturing Practice (GMP). Hospital pharmacists must ensure proper infrastructure, documentation, process control, and staff training. An important aspect of the standard is the monitoring of critical environmental parameters, such as temperature, humidity, and air quality in production and storage areas. These parameters must be continuously monitored to ensure that medicines are safe and effective. In the event of deviations from established limits, corrective actions must be taken promptly. This ensures the quality and safety of medicines and ensures that the hospital pharmacy meets international standards.

Continuous monitoring

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testo Saveris 1 guarantees seamless monitoring of all critical environmental parameters. The precise recording and analysis of this data ensures consistently high product and process quality, which is essential in highly sensitive and regulated environments.

 Immediate detection of deviations 

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The system detects and reports deviations from specified limit values in real time. This proactive notification allows potential problems to be identified and rectified at an early stage, minimizing production interruptions and quality losses. 

Seamless integration

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testo Saveris 1 is designed to integrate seamlessly into existing operational systems and processes. This ensures continuous data availability without interruptions, supported by state-of-the-art interfaces and protocols.

Avoidance of monitoring gaps 

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The use of highly reliable and versatile sensors effectively closes potential monitoring gaps. This is particularly important in production environments with high sensitivity and quality requirements.

Redundancy and reliability

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testo Saveris 1 is equipped with robust backup and redundancy mechanisms, which ensure uninterrupted monitoring even in the event of technical faults or system failures. This redundancy ensures maximum operational reliability.

High data integrity

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All recorded data is stored securely and protected against manipulation. This high level of data integrity ensures a reliable and complete history of the monitoring data, which is of great importance for audits and regulatory requirements.

Compliance with regulations

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testo Saveris 1 supports strict compliance with regulatory requirements through continuous and precise monitoring. This ensures that all legal and industry-specific requirements are met at all times.

Avoidance of quality losses

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Immediate detection of temperature or humidity fluctuations enables rapid correction and thus prevents quality losses. This reactive adaptation helps to maintain product quality.

Optimization of processes

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Continuous data acquisition and analysis with testo Saveris 1 enables in-depth process analysis. This leads to long-term optimization and efficiency gains that sustainably improve product quality and operational performance.

"Top 10 requirements to consider when designing your temperature monitoring system"

Discover Our Experts Panel! 


Want to learn from the best professionals in your field? Read our Expert Panel page and gain access to valuable insights, tips, and discussions from top experts. Whether you're looking for inspiration, knowledge, or new connections, you'll find it all here. Dive deeper into relevant topics and stay up-to-date with the latest trends! 

Marc Vandenbergh

Head of Quality

Stefan Van Vooren

Business Unit Manager Pharma

Laurent Van Zeebroeck

Junior Sales Manager

Interesting downloads

Testo system overview

White-paper - FDA 21 CFR Part 11

 

Let's meet at SIS Healthcare

Join us on 11-12-13 February 2025 at Sciencepark in Antwerp 

 
In 3 days, you'll explore innovations in ATMP, tackle supply chain challenges, and learn about cutting-edge technologies transforming industries. Engage with experts through keynotes, panels, and networking, and connect with healthcare professionals and students during relaxed site visits and an after-work gathering with food, music, and collaboration. 



Testo Experts Panel



 Welcome to our Experts Panel, where Testo experts share valuable insights into the pharmaceutical sector. Here, you can explore expert opinions, trends, and best practices that are shaping the future of pharma. Whether you're seeking advice on compliance, innovation, or market dynamics, our panel offers a wealth of knowledge to help guide your business decisions. 


5 Steps in getting ISO15189 certification

 ISO 15189 is an international standard that specifies the requirements for quality and competence in medical laboratories. It ensures that laboratories provide accurate and reliable test results, which are critical for patient care. One of the key areas covered by this standard is temperature monitoring, which is vital for maintaining the integrity of medical samples and reagents 

Our Projects


 “At Livlina we strongly believe in a high-tech approach” says Karel Van Besien, Director of Quality at Livlina. “For example, our largest warehouse in Sint-Niklaas is 20 years old, but because it was so progressive at the time, it still feels very modern today. When we started looking for a way to check the temperature for our new distribution center in Tessenderlo, we wanted an accurate and fully automated system with extensive data logging. In the pharmaceutical sector, traceability is particularly important, sometimes literally of vital importance, and if there is no data on, for example, the temperature during the entire chain, products may have to be destroyed. That could mean a financial hangover.”

Karel Van Besien
Director of Quality at Livlina 

360° GxP services


 

The testo Saveris data monitoring system enables users to save time and money with automated measurement data management. Other benefits include centralised documentation and a range of different alarm options. The system guarantees the reliable detection, storage and archival of measurement data in production processes, when storing and transporting pharmaceutical products and in clean room air conditioning.

Testo offers full services for qualification/validation. The “Premium” package offers you fully comprehensive GAMP 5 validation, which can include your specific requirements for implementing risk analysis, after which you can skip directly to productive use. The modular and detailed risk analysis process and coherent validation documentation facilitates not only traceability but also the evaluation of future system alterations, quickly and securely. 

Finally we offer also on-site services for mapping & calibration (ISO 9001 & ISO 1702). Our engineers and technicians calibrate your measuring systems following your specific requirements. In this way, you may be sure that all calibrations and documentations are performed according to the standards reproducible and traceable. 


"In the pharmaceutical industry, unwavering commitment to instrument calibration is vital, as it ensures data integrity and product safety, highlighting the essential role of precision in protecting public health."

Marc Vandenbergh
Head of Quality

Qualification and thermal mapping of critical areas in pharmaceutical storage:

Goods and products that are sensitive to temperatures must be manufactured, stored and transported in qualified facilities, with qualified equipment and using validated processes. Here, the three sub-processes of validation, qualification and mapping are of particular importance. Among other things, critical temperature ranges can be identified and specifically monitored to ensure that the safety of the stored pharmaceuticals is not compromised at any time.

 "Ensuring product quality in pharmaceutical logistics"

In this Webinar you explore GxP standards and the critical role of environmental monitoring in maintaining product integrity. Discover practical strategies for ensuring medicine safety and hear firsthand from logistics leader Simon Hegele.


Gain insights into best practices for pharmaceutical supply chain management, including vaccine storage. Aimed at industry professionals, this webinar offers valuable guidance for enhancing product quality and patient safety


"What if you could choose between different communication technologies in the same monitoring system?" 

Your key benefits

  • Real-time monitoring: Keep an eye on all quality-related environmental parameters at all times.
  • Efficient documentation: Time and resource-saving recording and documentation of measured values.
  • Intelligent alarm system: Use advanced alarm features to anticipate and prevent critical events. 

"Always one step ahead"

 

A guide to early problem detection and securing the working environment in environmental monitoring. 

Well-implemented alarm & escalation management is crucial for operational efficiency and quality assurance in environments with critical temperature and humidity requirements.

From complex to easy:
FDA 21 CFR Part 11 in temperature monitoring


21 CFR Part 11 is a regulation set by the U.S. Food and Drug Administration (FDA) that establishes criteria for the use of electronic records and electronic signatures (ERES) in the pharmaceutical, biotechnology, and other industries regulated by FDA. This part of the Code of Federal Regulations ensures that electronic records and signatures have the same level of trustworthiness and reliability as traditional paper records and handwritten signatures.


5 stories – 1 solution:


How testo Saveris 1 convinces in use

When it comes to environmental monitoring, companies are constantly faced with complex challenges: inadequate WLAN coverage, limitations in the technical equipment available to teams, the need for seamless calibration and integration of different measurement systems, and the need for customized consulting services. These scenarios require well thought-out solutions.

How can we at Testo meet these diverse requirements without us or our customers having to compromise on quality and safety? Here, five success stories show how testo Saveris 1 overcomes these challenges and improves efficiency and reliability in different environments. 

What to do if there is insufficient WLAN coverage ?

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A long-standing customer maintains its laboratories in a historic industrial building with impressive and unique architecture. But this aesthetic brings a significant problem with it: The historic building structure with extremely thick walls and a nested floor plan makes it almost impossible to achieve seamless WLAN coverage. This challenge not only affected the researchers' daily work, but also raised questions about data security and integrity.

Our task was clearly defined: We had to implement a reliable monitoring system that was capable of ensuring continuous and secure data transmissions despite the adverse structural conditions.

The solution was the modular data logger concept of testo Saveris 1, which allowed our customer to choose between WLAN, radio and Ethernet. In this way, it was possible to switch to other transmission technologies when the WLAN signal was weak, enabling continuous and seamless monitoring of critical data.

How can employees be alerted about limit violations without SMS and e-mail ?

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The employees in the laboratory of a leading chemical company were unable to carry their company hardware with them at all times, which made it difficult to communicate alarms via email or text message in the event of limit violations. This led to delays in response and potential risks in the process.

The solution was the innovative alarm function via webhooks, which activates a signal light in the laboratory. As soon as a parameter falls outside the permissible range, the signal lamp lights up and immediately signals to the teams that there was a problem. In addition, the company installed a central screen showing the floor plan-based cockpit of the testo Saveris 1 software. This enabled employees to see the exact position and status of each measuring point.

These adjustments made it possible for employees to be constantly informed about the current status of the measuring points and to react quickly to critical situations, even without their own company devices. By introducing the decentralized alarm function and the cockpit display, the company was able to significantly improve safety and efficiency in the laboratory.

How to avoid measurement gaps during calibration ?

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In the ultra-modern warehouse of a customer in the logistics sector, those responsible were faced with a crucial challenge: ensuring seamless monitoring and documentation, even during the calibration phases of the sensors. Traditionally, calibration of the analog sensors led to interruptions, which posed a problem for continuous quality control and stock monitoring.

The innovative solution came in the form of testo Saveris 1 digital sensors. Our customer equipped its warehouse with this advanced technology, which enabled the sensors to be calibrated separately from the data logger. This meant that sensors in need of calibration could be easily replaced with spare sensors without interrupting data recording.

By switching to digital sensors, the company not only eliminated measurement gaps during calibration times, but also increased the overall efficiency and accuracy of its warehouse monitoring. The changeover proved to be a crucial step in maintaining standard-compliant documentation, which is essential for meeting the strict quality and safety standards in warehousing.

Is it possible to display measured values from different sources on one dashboard ?

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An industry leader in the pharmaceutical industry wanted a clearer overview of various measurement parameters from different sources. The complex data landscape made it difficult for the team to react quickly to changes and gain comprehensive insights.

The introduction of Testo's innovative Rest API has ushered in a transformative change. This enabled seamless integration with the testo Saveris server, allowing measurement and system data to be retrieved and processed effectively. By using this solution, the company was able to develop a centralized dashboard that not only brought together various data streams, but also connected them to other important operational information in a meaningful way.

The redesigned dashboard provided the company with unprecedented insight into its operations, improved responsiveness and optimized monitoring of plant performance.

Which support services can Testo offer companies in the field of environmental monitoring ?

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An up-and-coming biotechnology company was confronted with a variety of technical requirements and support needs. The diversity of the projects and the complexity of the technologies used required a flexible yet robust support solution.

In this situation, the team discovered Testo's diverse helpdesk packages. The packages on offer range from solid basics in the basic package to comprehensive all-round support in the premium package. This flexibility allowed the company to choose a customized service solution that was precisely tailored to its specific needs and challenges.

By opting for the Advanced package, which offers a fast response time and an extended scope of support, those responsible were able to significantly increase the efficiency of their research and development work. The availability of extended support services helped to resolve technical issues faster and minimize downtime, ultimately driving our client's productivity and innovation.

Testo's helpdesk packages, our customer not only found the ideal support for their current needs, but also secured the possibility of adapting the support in the event of future changes or expansions to their business activities.

Connect with your LIMS

REST-API: Interface for Testo Saveris 1

Centralize your monitoring
Display all parameters on a unified dashboard
Connect with you LIMS

 

Pharmaceutical transport

When transporting pharmaceuticals, clearly defined temperature and humidity limit values have to be observed. Seamlessly and continuously. If these limits are violated, the active substances or the composition of the drugs may be irreversibly altered. 

"Revolutionize patient care and enhance clinical trial efficiency with our cutting-edge temperature monitoring solutions, ensuring precision, compliance, and real-time data insights tailored for the pharmaceutical industry."


Stefan Van Vooren
Testo Pharma Solutions

Contact us:

Belgium

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